Functional Remediation for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370668
• Other study ID #: PI08/90094
• Secondary ID: PI080180
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: June 9, 2011
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Centro de Investigación Biomédica en Red de Salud Mental
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of the population. Recent research point at the relevance and persistence of cognitive dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment has been classically associated with schizophrenia and not bipolar disorder. Current findings suggest that some intervention is needed in order to improve not only affective symptoms but also cognitive dysfunctions, so that patients could benefit from cognitive remediation techniques to improve cognitive impairment and the functional outcome. There is no previous research on the efficacy of cognitive remediation programs on bipolar disorder.

Description:

The method consists of a randomized clinical trial with 3 arms: 1) one group (n=66) will receive a cognitive rehabilitation program + pharmacological treatment, 2) another group (n=66) will receive a psychoeducation program + pharmacological treatment, and 3) a control group (n=66) will only receive pharmacological treatment. A psychopathological, neuropsychological and functional assessment will be administered pre and post-intervention and a 12-month follow-up to assess the long term effects of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Outpatients

• Diagnosis of bipolar disorder type I or II, according to DSM-IV-TR 4ª Ed criteria

• Adult patients, aged between 18 and 55 years old

• Euthymic (YMRS < 6, HDRS < 8) for at least three months prior to study entry.

• Signed inform consent

• Severe or moderate functional impairment (FAST > 18)

Exclusion Criteria:

• IQ < 85

• Neurological illness

• Present diagnosis of substance abuse or dependence according to DSM-IV criteria the last three months

• Significant medical illness considered as severe by the study that may interfere with assessments

• having been enrolled in any kind of cognitive rehabilitation intervention the last two years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Functional remediation
The functional remediation program is composed of 21 weekly sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning. The program will be performed in an 12- to 15-patient group conducted by 2 experienced neuropsychologists with previous experience with bipolar patients and specific training on patients' group management.
• Psychoeducation
Group psychoeducation is a tested and manualized intervention consisting of 21 weekly sessions of 90 minutes aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences, and lifestyle regularity.
• Treatment as usual
The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Centro de Investigación Biomédica en Red de Salud Mental	Benito Menni, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital General Universitario Gregorio Marañon, Hospital Santiago Apóstol de Vitoria, Hospital Universitari de Bellvitge, Hospital Universitario de la Princesa, Universidad de Oviedo, University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment Short Test (FAST)	The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.	Baseline	No
Primary	Functional Assessment Short Test (FAST)	The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.	6 months	No
Primary	Functional Assessment Short Test (FAST)	The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.	12 months	No